Hiring: NairobiCity Newsroom
Status
Open
Source
MyJobMag
• Job Type Full Time
• Qualification MBA/MSc/MA , Professional Certificate
• Experience 5 years
• Location Nairobi
• Job Field Finance / Accounting / Audit
• Monitor and support compliance with approvals issued by institutional, national and international Ethics Review Committees.
• Maintain a central regulatory tracking system for approved studies and research programmes at IHD.
• Review completeness and accuracy of ethics and regulatory files for approved studies and research programmes at IHD.
• Review and verify that requisite approvals are obtained for approved IHD studies and research programme before commencement of study activities.
• Monitor and flag approaching expiry dates for ethics approvals, permits and regulatory authorizations for approved studies and research programme at IHD.
• Monitor and verify implementation of approved protocols and amendments in line with ethics and regulatory committee requirements and conditions for approval.
• Develop, review and implement plans for routine annual compliance monitoring activities
• Review and verify adherence to approved protocols and Standard Operating Procedures.
• Review, identify and document protocol deviations and protocol violations.
• Support with monitoring for implementation of any corrective and preventative actions.
• Develop routine written compliance monitoring reports.
• Periodically review and advise on the use of approved informed consent forms.
• Periodically observe and advise whether participants receive adequate information during. consenting, and that consent is appropriately documented.
• Review and advice whether participant privacy and confidentiality is maintained.
• Review participant consenting relating to sample collection, storage and use.
• Review and advise on sample collection, sample labelling, sample processing and sample storage tools, processes and procedures.
• Review sample inventory management, sample transportation, sample shipment, sample reception and long-term storage processes and procedures.
• Identify ethics and regulatory compliance training needs.
• Organize and facilitate periodic ethics and regulatory compliance training sessions
• Provide training and regulatory updates to Investigators.
• Support onboarding and training of new research staff on ethics and regulatory compliance.
• Promote ethics, regulatory, and Good Clinical Practice principles.
• Review and advise on essential documents including the Investigator site files, staff training logs, delegation logs, screening logs, enrolment logs, regulatory correspondence, protocol version control and data archiving.
• Review and support compliance relating to participant confidentiality, secure data storage, access control, data anonymization, data sharing, and material transfer agreements.
• Review and support readiness for research audits, regulatory inspections, and implementation of audit recommendations.
• Prepare periodic reports summarizing compliance monitoring activities, findings, corrective actions, institutional compliance and recommendations for continuous improvement.
• Master’s degree in public health, Clinical research, Epidemiology, Health Sciences, Pharmacy, Nursing, Medicine, or a related discipline
• Minimum five years' experience in research ethics, regulation, governance, clinical research management, quality assurance or regulatory affairs
• Demonstrated knowledge of research ethics, regulatory and governance frameworks.
• Certification in Good Clinical Practice (ICH-GCP).
• Experience supporting institutional ethics review committees, research audits or research inspections is an added advantage
• High integrity standards, ethical standards and ability to manage confidential information
• Excellent analytical skills, organizational skills and attention to detail
• Strong written communication skills, diplomacy skills and professional judgement skills
• Ability to work independently and/or with minimal supervision
• Excellent interpersonal skills and the ability to build and maintain harmonious working relationships with diverse stakeholders.
• Professionalism, tact, and resilience when working under pressure or when managing challenging situations.
• A collaborative and respectful approach that fosters teamwork and advances a positive working environment.
• Qualification MBA/MSc/MA , Professional Certificate
• Experience 5 years
• Location Nairobi
• Job Field Finance / Accounting / Audit
• Monitor and support compliance with approvals issued by institutional, national and international Ethics Review Committees.
• Maintain a central regulatory tracking system for approved studies and research programmes at IHD.
• Review completeness and accuracy of ethics and regulatory files for approved studies and research programmes at IHD.
• Review and verify that requisite approvals are obtained for approved IHD studies and research programme before commencement of study activities.
• Monitor and flag approaching expiry dates for ethics approvals, permits and regulatory authorizations for approved studies and research programme at IHD.
• Monitor and verify implementation of approved protocols and amendments in line with ethics and regulatory committee requirements and conditions for approval.
• Develop, review and implement plans for routine annual compliance monitoring activities
• Review and verify adherence to approved protocols and Standard Operating Procedures.
• Review, identify and document protocol deviations and protocol violations.
• Support with monitoring for implementation of any corrective and preventative actions.
• Develop routine written compliance monitoring reports.
• Periodically review and advise on the use of approved informed consent forms.
• Periodically observe and advise whether participants receive adequate information during. consenting, and that consent is appropriately documented.
• Review and advice whether participant privacy and confidentiality is maintained.
• Review participant consenting relating to sample collection, storage and use.
• Review and advise on sample collection, sample labelling, sample processing and sample storage tools, processes and procedures.
• Review sample inventory management, sample transportation, sample shipment, sample reception and long-term storage processes and procedures.
• Identify ethics and regulatory compliance training needs.
• Organize and facilitate periodic ethics and regulatory compliance training sessions
• Provide training and regulatory updates to Investigators.
• Support onboarding and training of new research staff on ethics and regulatory compliance.
• Promote ethics, regulatory, and Good Clinical Practice principles.
• Review and advise on essential documents including the Investigator site files, staff training logs, delegation logs, screening logs, enrolment logs, regulatory correspondence, protocol version control and data archiving.
• Review and support compliance relating to participant confidentiality, secure data storage, access control, data anonymization, data sharing, and material transfer agreements.
• Review and support readiness for research audits, regulatory inspections, and implementation of audit recommendations.
• Prepare periodic reports summarizing compliance monitoring activities, findings, corrective actions, institutional compliance and recommendations for continuous improvement.
• Master’s degree in public health, Clinical research, Epidemiology, Health Sciences, Pharmacy, Nursing, Medicine, or a related discipline
• Minimum five years' experience in research ethics, regulation, governance, clinical research management, quality assurance or regulatory affairs
• Demonstrated knowledge of research ethics, regulatory and governance frameworks.
• Certification in Good Clinical Practice (ICH-GCP).
• Experience supporting institutional ethics review committees, research audits or research inspections is an added advantage
• High integrity standards, ethical standards and ability to manage confidential information
• Excellent analytical skills, organizational skills and attention to detail
• Strong written communication skills, diplomacy skills and professional judgement skills
• Ability to work independently and/or with minimal supervision
• Excellent interpersonal skills and the ability to build and maintain harmonious working relationships with diverse stakeholders.
• Professionalism, tact, and resilience when working under pressure or when managing challenging situations.
• A collaborative and respectful approach that fosters teamwork and advances a positive working environment.
• Job Type Full Time
• Qualification MBA/MSc/MA , Professional Certificate
• Experience 5 years
• Location Nairobi
• Job Field Finance / Accounting / Audit
• Monitor and support compliance with approvals issued by institutional, national and international Ethics Review Committees.
• Maintain a central regulatory tracking system for approved studies and research programmes at IHD.
• Review completeness and accuracy of ethics and regulatory files for approved studies and research programmes at IHD.
• Review and verify that requisite approvals are obtained for approved IHD studies and research programme before commencement of study activities.
• Monitor and flag approaching expiry dates for ethics approvals, permits and regulatory authorizations for approved studies and research programme at IHD.
• Monitor and verify implementation of approved protocols and amendments in line with ethics and regulatory committee requirements and conditions for approval.
• Develop, review and implement plans for routine annual compliance monitoring activities
• Review and verify adherence to approved protocols and Standard Operating Procedures.
• Review, identify and document protocol deviations and protocol violations.
• Support with monitoring for implementation of any corrective and preventative actions.
• Develop routine written compliance monitoring reports.
• Periodically review and advise on the use of approved informed consent forms.
• Periodically observe and advise whether participants receive adequate information during. consenting, and that consent is appropriately documented.
• Review and advice whether participant privacy and confidentiality is maintained.
• Review participant consenting relating to sample collection, storage and use.
• Review and advise on sample collection, sample labelling, sample processing and sample storage tools, processes and procedures.
• Review sample inventory management, sample transportation, sample shipment, sample reception and long-term storage processes and procedures.
• Identify ethics and regulatory compliance training needs.
• Organize and facilitate periodic ethics and regulatory compliance training sessions
• Provide training and regulatory updates to Investigators.
• Support onboarding and training of new research staff on ethics and regulatory compliance.
• Promote ethics, regulatory, and Good Clinical Practice principles.
• Review and advise on essential documents including the Investigator site files, staff training logs, delegation logs, screening logs, enrolment logs, regulatory correspondence, protocol version control and data archiving.
• Review and support compliance relating to participant confidentiality, secure data storage, access control, data anonymization, data sharing, and material transfer agreements.
• Review and support readiness for research audits, regulatory inspections, and implementation of audit recommendations.
• Prepare periodic reports summarizing compliance monitoring activities, findings, corrective actions, institutional compliance and recommendations for continuous improvement.
• Master’s degree in public health, Clinical research, Epidemiology, Health Sciences, Pharmacy, Nursing, Medicine, or a related discipline
• Minimum five years' experience in research ethics, regulation, governance, clinical research management, quality assurance or regulatory affairs
• Demonstrated knowledge of research ethics, regulatory and governance frameworks.
• Certification in Good Clinical Practice (ICH-GCP).
• Experience supporting institutional ethics review committees, research audits or research inspections is an added advantage
• High integrity standards, ethical standards and ability to manage confidential information
• Excellent analytical skills, organizational skills and attention to detail
• Strong written communication skills, diplomacy skills and professional judgement skills
• Ability to work independently and/or with minimal supervision
• Excellent interpersonal skills and the ability to build and maintain harmonious working relationships with diverse stakeholders.
• Professionalism, tact, and resilience when working under pressure or when managing challenging situations.
• A collaborative and respectful approach that fosters teamwork and advances a positive working environment.
Listed on MyJobMag — applications are handled there, not on NairobiCity.
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